Activists cry foul over new HIV drug monopoly

Only one Indian drug maker, Emcure, will be allowed to sell the medicine in the Indian private market, because of a licensing agreement with Viiv HealthcareDIVYA RAJAGOPAL | ET Bureau | December 27, 2016, 06:31 IST

GSK and Emcure did not respond to emails asking them about price at which they will be selling this drug in India.MUMBAI: Doctors and aid organisations have called upon the Competition Commission of India and the price regulator to step in to ward off the monopoly over a new HIV drug, dolutegravir, which received the approval of the Indian drug controller last month.

Dolutegravir — sold by GlaxoSmithKline's Viiv Healthcare unit under the Trivicay brand — is considered the best-in-class HIV drug as it reduces virus levels faster and has a high barrier to resistance compared to previous line of drugs.

However, only one Indian drug maker, Emcure, will be allowed to sell the medicine in the Indian private market, because of a licensing agreement with Viiv Healthcare under the Medicine Patent Pool.

This is despite Indian generic makers like Cipla, Aurobindo Pharma, Hetero and Strides Arcolab having licence to sell this drug in nearly 50 other low- and middle-income countries. However, these companies can sell the drug through public sector tenders or through NGOs in India. Activists call this condition restrictive and anticompetitive.

"It is such an irony that Indian drug makers who are known to provide affordable medicines to the world will not be able to sell the drug in India, as ViiV has effectively blocked access to the drug through licence conditions that limit its supply to public sector entities and NGOs in India with prior permission from the company – and not through private sales," said Leena Menghaney of Doctors Without Borders, an aid organisation.

"The CCI or the pricing regulator (the National Pharmaceutical Pricing Authority) should step in to make sure that this drug doesn't become monopoly."

GSK and Emcure did not respond to emails asking them about price at which they will be selling this drug in India.

Some doctors are concerned about how the drug would be priced. "If priced premium, many patients would lose out on benefit of a good drug," said Dr Mandar Kubal, director of Mumbai-based Infectious Diseases & Pulmonary Care Pvt Ltd. If the licence was not restrictive, the presence of more companies in the market would have driven the price lower, like it happened in the case of new class of Hepatitis-C drugs, Kubal added.

"If you position it as first line, then pricing is key, and I don't understand this licensing pact so I expect eventually other drug companies too would get licence," said Dr Sanjay Pujari, an HIV specialist.

In India, about 2 million patients are under anti-retrovirals (ARVs) and almost 90 per cent of the public requirement for ARVs is procured by the National AIDS Control Organisation (NACO).

However, the HIV patients say NACO is far behind when it comes to adding new therapy lines to its treatment guidelines, which makes patients to depend on private markets.

The anti-HIV market in India is estimated to be Rs 300 crore, with an 11 per cent growth rate, according to research firm AWACS. The cost of treatment for raltegravir, which is the second best in line treatment for HIV, is around Rs 8,000 per month.

"Without access to dolutegravir in the private sector, people living with HIV who have developed resistance to existing HIV medicines will not be able to get effective treatment they need to stay alive," said Loon Gangte of the Delhi Network of Positive People.

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